MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED SURGICAL LIGHTING SYSTEM

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

A steris technician arrived on-site to inspect the lighting system subject of the complaint.The technician confirmed that one label was missing; he also observed that some of the other labels on the lighting system appeared worn.The lighting system subject of the event was manufactured in 2009, making it approximately 11 years old.While on-site during his inspection, user facility personnel informed the technician that the label had fallen off during a patient procedure, and that the label had contacted the patient.This resulted in a delay to the procedure, as the sterile field had to be re-established.The procedure was completed successfully; no report of injury.The labels applied to the harmony led lighting systems contain a permanent acrylic adhesive backing, and are not expected to peel or fray over time.However, degradation may occur with the use of improper cleaning chemicals or by user facility personnel allowing excess cleaning fluid to remain on the labels.The harmony led operator manual states (1-3), "cleaning and disinfecting agents used on this lighting system must be certified by their manufacturer to be compatible with the following materials: polycarbonate, polyetherimide, santoprene.Use only recommended cleaning/disinfecting and/or anti-static agents on this light.Some degree of staining, pitting and/or discoloration could occur if a phenolic-, iodophor- or glutaraldehyde-based disinfectant is used on the surfaces of this lighthead." additionally, the operator manual states, "do not spray any cleaning product directly onto the lighthead, modem chassis, or any system components.Dampen a soft cloth with the cleaning solution and wring out the excess moisture." the technician replaced the labels and returned the lighting system to service.The technician also counseled user facility personnel on proper cleaning practices for the lighting system.A 3-year complaint review determined this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that a label had fallen off their harmony led surgical lighting system.

• Brand Name: HARMONY LED SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10830805
• MDR Text Key: 234283389
• Report Number: 1043572-2020-00056
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1